MAUDE Adverse Event Report: UNKNOWN 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5LXO2

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported by provider that the irc5lxo2 concentrator will intermittently turn on and off by itself.Per tech, unit needs sent in for repair.The provider had barely any information and didn't have an account number to reference.No additional information is available as the provider disconnected before call could be transferred.

• Brand Name: 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4556678
• MDR Text Key: 5548589
• Report Number: 1525712-2015-01534
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5LXO2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other